Trial record 3 of 34 for:    MEAL prostate

Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer (TasQ003)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT02057666
First received: February 6, 2014
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

To confirm the effect of tasquinimod in delaying disease progression or death as compared with placebo in chemo-naïve patients with metastatic castrate-resistant prostate cancer (mCRPC).


Condition Intervention Phase
Asian Chemo-naïve Patients With Metastatic Castrate-resistant Prostate Cancer
Drug: Tasquinimod
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Double-Blind, Placebo-Controlled Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Time to Radiological Progression-Free Survival [PFS] [ Time Frame: Every 3 months, up to 3 years ] [ Designated as safety issue: No ]
    PFS is defined as the time from the date of randomisation to the date of radiological progression (confirmed by the central imaging assessment) or death due to any cause.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Every 3 months, up to 3 years ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from randomisation to death due to any cause

  • Time to Symptomatic PFS based on local assessment [ Time Frame: Every 3 months, up to 3 years ] [ Designated as safety issue: No ]
    Symptomatic PFS, defined as the time from the date of randomisation to the date of appearance of pain (using pain visual analogue scale [VAS]) at a site with documented disease and analgesic use, or skeletal-related events, or death due to prostate cancer, whichever occurs first.

  • Time from randomisation to further treatment for prostate cancer. [ Time Frame: Every 3 months, up to 3 years ] [ Designated as safety issue: No ]
  • Quality of Life (QoL) [ Time Frame: Every 3 months, up to 3 years ] [ Designated as safety issue: No ]
    Quality of Life (QoL) measured by the Functional Assessment of Cancer Therapy Prostate Module (FACT-P) questionnaire and by the EuroQol 5-Dimension QoL Instrument (EQ-5D).


Estimated Enrollment: 300
Study Start Date: January 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tasquinimod
Main study: 1 capsule (0.25, 0.50 or 1 mg) daily, taken orally once a day with water and food (preferably the main evening meal).
Drug: Tasquinimod
A patient will initially receive 0.25 mg/day dose which will then be titrated through 0.5 mg/day (from Day 15) to a maximum of 1mg/day (from Day 29). If tolerability issues arise at 0.5 or 1 mg/day, patients will have their dose reduced to 0.25 or 0.5 mg/day, respectively.
Placebo Comparator: Placebo
1 capsule daily, taken orally once a day with water and food (preferably the main evening meal).
Drug: Placebo
Placebo capsules are identical to tasquinimod capsules in appearance and excipients but exclude the active compound (tasquinimod), to be taken orally once a day with water and food (preferably the main evening meal).

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asian male aged at least 20 years at the time of signing the informed consent form
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate
  • Evidence of metastatic disease (bone and/or visceral), excluding node lesion only, on radiographic examination, whether from bone scan (bone lesions) or other imaging modality (computed tomography [CT] scan/magnetic resonance imaging [MRI])
  • Chemical or surgical castration verified by levels of serum testosterone ≤50 ng/dL (1.75 nmol/L), Evidence of progressive disease after castration levels of testosterone have been achieved

Exclusion Criteria:

  • Cytotoxic chemotherapy for the treatment of prostate cancer within 2 years prior to the start of study treatment
  • Previous anticancer therapy using radiation, biologics or vaccines and including sipuleucel-T (Provenge®) within 4 weeks prior to the start of study treatment and abiraterone, TAK700 or MDV3100 within 2 weeks prior to the start of study treatment. Before inclusion, abiraterone, TAK700 or MDV3100 related adverse effect must have been resolved to NCI-CTCAE v4.03 Grade ≤1. If radiation therapy is applied after Baseline scan, a new Baseline scan needs to be done at least 4 weeks after the radiation therapy
  • Therapy with antiandrogens within 4 weeks (within 6 weeks for bicalutamide e.g. Casodex®) prior to the start of study treatment
  • Concurrent use of other anticancer agents or treatments, with the exception of ongoing treatment with luteinising hormone-releasing hormone agonists or antagonists, denosumab (Prolia®) or bisphosphonate (e.g. zoledronic acid), which are allowed. Ongoing treatment should be kept at a stable schedule; however, if medically required, a change of dose, compound, or both is allowed
  • Prostate cancer pain that requires ongoing treatment with narcotic analgesics or warrants the initiation of radio- or chemotherapy
  • Prostate-Specific Antigen (PSA) >100 ng/mL
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057666

Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
China
Active, not recruiting
Beijing, China
Not yet recruiting
Beijing, China
Active, not recruiting
Changsha, China
Recruiting
Chengdu, China
Not yet recruiting
Chengdu, China
Not yet recruiting
Chongqing, China
Not yet recruiting
Guangzhou, China
Not yet recruiting
Hangzhou, China
Active, not recruiting
Nanchang, China
Not yet recruiting
Nanjing, China
Not yet recruiting
Shanghai, China
Active, not recruiting
Shanghai, China
Recruiting
Shanghai, China
Recruiting
Shantou, China
Recruiting
Soochow, China
Not yet recruiting
Tianjin, China
Recruiting
Wenzhou, China
Not yet recruiting
Wuhan, China
Korea, Republic of
Recruiting
Cheongju, Korea, Republic of
Recruiting
Seoul, Korea, Republic of
Active, not recruiting
Seoul, Korea, Republic of
Taiwan
Recruiting
Taichung, Taiwan
Active, not recruiting
Taipei, Taiwan
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Medical Director Uro-Oncology Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02057666     History of Changes
Other Study ID Numbers: 8-55-58102-003
Study First Received: February 6, 2014
Last Updated: June 30, 2014
Health Authority: China: Food and Drug Administration
Taiwan : Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 19, 2014